Zithromax

Product NDC
67296-0020
11-digit product format
672960020
Labeler code
67296
Product ID
67296-0020_3ddecd2f-ea4c-536f-e063-6294a90a7936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
NDA050711
Marketing category
NDA
Marketing start
1996-07-18
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zithromax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
Rxcui212446, 308460

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0020-1Zithromax4 in 1 BOTTLETABLET, FILM COATED41
67296-0020-2Zithromax6 in 1 BOTTLETABLET, FILM COATED61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN3ddecd25-dc32-a2af-e063-6294a90a526d1
212446Zithromax 250 MG Oral TabletPSN3ddecd25-dc32-a2af-e063-6294a90a526d1
212446azithromycin 250 MG Oral Tablet [Zithromax]SBD3ddecd25-dc32-a2af-e063-6294a90a526d1
308460azithromycin 250 MG Oral TabletSCD3ddecd25-dc32-a2af-e063-6294a90a526d1
212446Zithromax 250 MG Oral TabletSY3ddecd25-dc32-a2af-e063-6294a90a526d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-0020-1672960020014 TABLET, FILM COATED in 1 BOTTLE (67296-0020-1) 1996-07-18NoNoCurrent
67296-0020-2672960020026 TABLET, FILM COATED in 1 BOTTLE (67296-0020-2) 1996-07-18NoNoCurrent